K240598 is an FDA 510(k) clearance for the Maestro System (REF100). This device is classified as a Table, Operating-room, Ac-powered (Class I - General Controls, product code FQO).
Submitted by Moon Surgical (Paris, FR). The FDA issued a Cleared decision on June 3, 2024, 91 days after receiving the submission on March 4, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4960.
| 510(k) Number | K240598 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2024 |
| Decision Date | June 03, 2024 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FQO - Table, Operating-room, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4960 |